Traumatic InjuryADVISENCT06804226
Advancing Discussions Using a Video-based Support Tool About End-of-life Care
A study testing Video conversation aid in people with Traumatic Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- Video conversation aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- English or Spanish speaking
- admitted to any level of care following trauma
Who cannot join
- Prisoners
- Existing do not resuscitate (DNR)/do not intubate (DNI)
- Patients admitted while on hospice
- Patients not expected to survive over 24-48 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Thaddeus J Puzio, MD, MS, FACS, 713-500-7218, Thaddeus.J.Puzio@uth.tmc.edu
Erin Fox, (713) 500-7965, Erin.E.Fox@uth.tmc.edu
About this study
Official title: Advancing Discussions Using a Video-based Support Tool About End-of-life Care: the ADVISE Project
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults
- Conditions
- Traumatic Injury
- Being tested
- Video conversation aid, Usual Care
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video conversation aidBehavioural
A video conversation aid which provides information regarding life-sustaining care and encourages further goals of care discussions with a healthcare provider will be shown to patients or their surrogates (for those incapacitated and unable to make their own decisions) on admission or within 48 hours whenever feasible
Usual CareBehavioural
Participants and/or surrogates will participate in discussions surrounding life-sustaining care at healthcare provider discretion.
| Study group | Role | What they receive |
|---|---|---|
| Video conversation aid | Experimental | Not described Receives: Behavioral: Video conversation aid |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who had a transition in code status from full code
Data will be reported categorically as number of participants who transitioned from full code to DNR/DNI, DNR, ok for intubation, or Comfort measures only
Measured: at time of discharge (about 5 days after admission)
Secondary outcomes (9)
Percentage of participants that recognize survival after Cardiopulmonary resuscitation (CPR) as less than 50 percent as assessed by a survey
Measured: at time of discharge (about 5 days after admission)
Number of participants that received information about life-sustaining care outcomes as assessed by a survey
Measured: at time of discharge (about 5 days after admission)
Number of participants that desire more information regarding life-sustaining care as assessed by a survey
Measured: at time of discharge (about 5 days after admission)
Number of participants that had hospital-free days
Measured: in the first 30 days after admission
Number of participants that had ICU-free days
Measured: at time of discharge (about 5 days after admission)
Discharge disposition
Data will be reported categorically as number of participants that were discharged to home, nursing facility, rehab facility, long term care hospital, hospice or number of participants that die
Measured: at time of discharge (about 5 days after admission)
Number of participants that had ventilator-free days
Measured: at time of discharge (about 5 days after admission)
Decisional conflict score as assessed by the Decisional Conflict Scale
This is a 4 item questionnaire, each is scored as 0(no) or 1(yes), for a maximum score of 4, higher score indicating no decisional conflict
Measured: at time of discharge (about 5 days after admission)
Number of interventional procedures
Procedures include tracheostomy, feeding tube placement, dialysis initiation
Measured: at time of discharge (about 5 days after admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start17 Mar 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thaddeus J. Puzio, The University of Texas Health Science Center, Houston
- Investigators
- Thaddeus J Puzio, MD, MS, FACS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804226
- Sponsor's protocol ID
- HSC-MS-24-1256
- Acronym
- ADVISE
- Status last verified
- Mar 2025
- First submitted
- 28 Jan 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fajemisin MO, Karpe AS, Martinez Ugarte S, Blakely ML, Khraish G, Sanghvi S, Lee JL, Kao LS, Puzio TJ. Advancing Discussions Using a Video-Based Support Tool About End-of-Life Care (ADVISE): Protocol for a Single-Center Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 18;15:e87690. doi: 10.2196/87690.
PubMed 42314159
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Discussions Using a Video-based Support Tool About End-of-life Care: the ADVISE Project
- ClinicalTrials.gov ID
- NCT06804226
- Acronym / sponsor ID
- ADVISE / HSC-MS-24-1256
- Conditions
- Traumatic Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness and implementation considerations of a video aid to improve communication and patient-centered outcomes in older injured adults
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video conversation aid | Experimental | Behavioral: Video conversation aid |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- English or Spanish speaking
- admitted to any level of care following trauma
Key exclusion criteria (4 listed)
- Prisoners
- Existing do not resuscitate (DNR)/do not intubate (DNI)
- Patients admitted while on hospice
- Patients not expected to survive over 24-48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video conversation aidA video conversation aid which provides information regarding life-sustaining care and encourages further goals of care discussions with a healthcare provider will be shown to patients or their surrogates (for those incapacitated and unable to make their own decisions) on admission or within 48 hours whenever feasible | Behavioural | Video conversation aid |
| Usual CareParticipants and/or surrogates will participate in discussions surrounding life-sustaining care at healthcare provider discretion. | Behavioural | Usual Care |
Primary outcome
Number of participants who had a transition in code status from full code
Time frame: at time of discharge (about 5 days after admission)
Data will be reported categorically as number of participants who transitioned from full code to DNR/DNI, DNR, ok for intubation, or Comfort measures only
9 secondary outcomes
Percentage of participants that recognize survival after Cardiopulmonary resuscitation (CPR) as less than 50 percent as assessed by a survey
Time frame: at time of discharge (about 5 days after admission)
Number of participants that received information about life-sustaining care outcomes as assessed by a survey
Time frame: at time of discharge (about 5 days after admission)
Number of participants that desire more information regarding life-sustaining care as assessed by a survey
Time frame: at time of discharge (about 5 days after admission)
Number of participants that had hospital-free days
Time frame: in the first 30 days after admission
Number of participants that had ICU-free days
Time frame: at time of discharge (about 5 days after admission)
Discharge disposition
Time frame: at time of discharge (about 5 days after admission)
Number of participants that had ventilator-free days
Time frame: at time of discharge (about 5 days after admission)
Decisional conflict score as assessed by the Decisional Conflict Scale
Time frame: at time of discharge (about 5 days after admission)
Number of interventional procedures
Time frame: at time of discharge (about 5 days after admission)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 42314159Fajemisin MO, Karpe AS, Martinez Ugarte S, Blakely ML, Khraish G, Sanghvi S, Lee JL, Kao LS, Puzio TJ. Advancing Discussions Using a Video-Based Support Tool About End-of-Life Care (ADVISE): Protocol for a Single-Center Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 18;15:e87690. doi: 10.2196/87690.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thaddeus J Puzio, MD, MS, FACS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video conversation aid in people with Traumatic Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thaddeus J Puzio, MD, MS, FACS (713-500-7218, Thaddeus.J.Puzio@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who had a transition in code status from full code (time frame: at time of discharge (about 5 days after admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06804226, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.